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Are We Ready for Designer Babies? Analysis of Law, Policy and Ethics Surrounding Germline Genetic Engineering

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Are We Ready for Designer Babies? Analysis of Law, Policy and Ethics Surrounding Germline Genetic Engineering MUMBAI SILICON VALLEY BANGALORE SINGAPORE MUMBAI BKC NEW DELHI MUNICH NEW YORK Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Strategic, Legal, Tax and Ethical issues June 2019 © Copyright 2019 Nishith Desai Associates www.nishithdesai.com Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Strategic, Legal, Tax and Ethical Issues June 2019 [email protected] DMS Code: No 480049v2 © Nishith Desai Associates 2019 Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering About NDA At Nishith Desai Associates, we have earned the reputation of being Asia’s most Innovative Law Firm – and the go-to specialists for companies around the world, looking to conduct businesses in India and for Indian companies considering business expansion abroad. In fact, we have conceptualized and created a state-of-the-art Blue Sky Thinking and Research Campus, Imaginarium Aligunjan, an international institution dedicated to designing a premeditated future with an embedded strategic foresight capability. We are a research and strategy driven international firm with offices in Mumbai, Palo Alto (Silicon Valley), Bangalore, Singapore, New Delhi, Munich, and New York. Our team comprises of specialists who provide strategic advice on legal, regulatory, and tax related matters in an integrated manner basis key insights carefully culled from the allied industries. As an active participant in shaping India’s regulatory environment, we at NDA, have the expertise and more importantly – the VISION – to navigate its complexities. Our ongoing endeavors in conducting and facilitating original research in emerging areas of law has helped us develop unparalleled proficiency to anticipate legal obstacles, mitigate potential risks and identify new opportunities for our clients on a global scale. Simply put, for conglomerates looking to conduct business in the subcontinent, NDA takes the uncertainty out of new frontiers. As a firm of doyens, we pride ourselves in working with select clients within select verticals on complex matters. Our forte lies in providing innovative and strategic advice in futuristic areas of law such as those relating to Blockchain and virtual currencies, Internet of Things (IOT), Aviation, Artificial Intelligence, Privatization of Outer Space, Drones, Robotics, Virtual Reality, Ed-Tech, Med- Tech & Medical Devices and Nanotechnology with our key clientele comprising of marquee Fortune 500 corporations. NDA has been the proud recipient of the RSG - FT award for 2019, 2017, 2016, 2015, 2014 as the ‘Most Innovative Indian Law Firm’ and in 2016 we were awarded the ‘Most Innovative Law Firm - Asia Pacific,’ by Financial Times (London). We are a trust based, non-hierarchical, democratic organization that leverages research and knowledge to deliver extraordinary value to our clients. Datum, our unique employer proposition has been developed into a global case study, aptly titled ‘Management by Trust in a Democratic Enterprise,’ published by John Wiley & Sons, USA. © Nishith Desai Associates 2019 Provided upon request only Accolades A brief chronicle our firm’s global acclaim for its achievements and prowess through the years – IFLR1000: Tier 1 for Private Equity and Project Development: Telecommunications Networks. 2020, 2019, 2018, 2017, 2014 AsiaLaw Asia-Pacific Guide 2020: Tier 1 (Outstanding) for TMT, Labour & Employment, Private Equity, Regulatory and Tax FT Innovative Lawyers Asia Pacific 2019 Awards: NDA ranked 2nd in the Most Innovative Law Firm category (Asia-Pacific Headquartered) RSG-Financial Times: India’s Most Innovative Law Firm 2019, 2017, 2016, 2015, 2014 Chambers and Partners Asia Pacific: Band 1 for Employment, Lifesciences, Tax and TMT 2019, 2018, 2017, 2016, 2015 Benchmark Litigation Asia-Pacific: Tier 1 for Government & Regulatory and Tax 2019, 2018 Legal500: Tier 1 for Dispute, Tax, Investment Funds, Labour & Employment, TMT and Corporate M&A 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012 Who’s Who Legal 2019: Nishith Desai, Corporate Tax and Private Funds – Thought Leader Vikram Shroff, HR and Employment Law- Global Thought Leader Vaibhav Parikh, Data Practices - Thought Leader (India) Dr. Milind Antani, Pharma & Healthcare – only Indian Lawyer to be recognized for ‘Life sciences- Regulatory,’ for 5 years consecutively Merger Market 2018: Fastest growing M&A Law Firm in India Asia Mena Counsel’s In-House Community Firms Survey 2018: The only Indian Firm recognized for Life Sciences IFLR: Indian Firm of the Year 2013, 2012, 2011, 2010 IDEX Legal Awards 2015: Nishith Desai Associates won the “M&A Deal of the year”, “Best Dispute Management lawyer”, “Best Use of Innovation and Technology in a law firm” and “Best Dispute Management Firm” © Nishith Desai Associates 2019 Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Please see the last page of this paper for the most recent research papers by our experts. Disclaimer This report is a copy right of Nishith Desai Associates. No reader should act on the basis of any statement contained herein without seeking professional advice. The authors and the firm expressly disclaim all and any liabilitytoanypersonwhohasreadthisreport,or otherwise, in respect of anything, and of consequences of anything done, or omitted to be done by any such person in reliance upon the contents of this report. Contact For any help or assistance please email us on [email protected] or visit us at www.nishithdesai.com Acknowledgements Dr. Milind Antani [email protected] Darren Punnen [email protected] © Nishith Desai Associates 2019 Provided upon request only With genetic engineering, we will be able to increase the complexity of our DNA, and improve the human race. But it will be a slow process, because one will have to wait about 18 years to see the effect of changes to the genetic code – Stephen Hawking Transhumanism is the ethics and science of using things like biological and genetic engineering to transform our bodies and make us a more powerful species. – Dan Brown I don’t think we are going to see superman or a split in the species any time soon, because we just don’t know enough – Henry Greely, bioethicist I see nothing wrong ethically with the idea of correcting single gene defects through genetic engineering. But I am concerned about any other kind of intervention, for anything else would be an experiment, which would impose our will on future generations and take unreasonable chances with their welfare ... Thus, such intervention is beyond the scope of consideration. – Ian Wilmut in The Second Creation: Dolly and the Age of Biological Control Oh, happy day, when miracles take place And scientists control the human race, When we assume authority of human chromosomes, And assembly-line women, Conveyor-belt men Settle down in push-button homes.– Li’l Abner, “Oh, Happy Day” How could you do something like that? That’s horrible, going around altering the genetics of babies! How could you do that to my parents? – Children of an Elder God The cloning of humans is on most of the lists of things to worry about from Science, along with behaviour control, genetic engineering, transplanted heads, computer poetry and the unrestrained growth of plastic flowers. – Lewis Thomas © Nishith Desai Associates 2019 Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Genetic engineering has never been about saving the world, it’s about controlling the world. – Vandana Shiva India has the opportunity to be a leader in genetic engineering, It has institutions that no other country has. – Nina Fedoroff It is difficult to imagine a greater imposition than adding genes to future generations that changes the nature of future people. – Ian Wilmut The time to talk about it [genetic engineering to improve a baby’s genes] in schools and churches and magazines and debate societies is now. If you wait, five years from now the gene doctor will be hanging out the MAKE A SMARTER BABY sign down the street. – Arthur Caplan I suspect any worries about genetic engineering may be unnecessary. Genetic mutations have always happened naturally, anyway. – James Lovelock Genetic engineering is a result of science advancement, so I don’t think that in itself is bad. If used wisely, genetics can be beneficial, but they can be abused, too. – Hideo Kojima Right now people are interested in genetic engineering to help the human race. That’s a noble cause, and that’s where we should be heading. But once we get past that - once we understand what genetic diseases we can deal with - when we start thinking about the future, there’s an opportunity to create some new life-forms. – Jack Horner © Nishith Desai Associates 2019 Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Contents 1. EXECUTIVE SUMMARY 01 2. INTRODUCTION 02 I. Important concepts 02 3. LEGAL AND REGULATORY FRAMEWORK WITH ANALYSIS 05 I. India 05 II. USA 05 III. UK 06 IV. China 07 V. Japan 07 VI. Other Important Jurisdictions 08 4. RECENT MEDICAL AND TECHNOLOGICAL ADVANCES 09 5. ETHICAL ISSUES 10 6. INTELLECTUAL PROPERTY RIGHT ISSUE 12 7. LIMITATIONS AND CHALLENGES IN INDIA 14 8. THE PRESENT AND FUTURE OF DESIGNER BABIES IN INDIA – A CLARION CALL FOR CHANGE 15 9. DESIGNING THE LAW ON DESIGNER BABIES 16 10. CONCLUSION 17 OUR EXPERTISE IN PHARMACEUTICAL AND HEALTHCARE 18 I. Introduction 18 II. Services 18 © Nishith Desai Associates 2019 Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering 1. Executive summary Genetic Engineering is poised to create research into this unknown but welcome a revolution that may lead to significant field. It definitely brings to light certain social, ethical and legal issues considering its impact ethical and religious concerns surrounding on human lives and possibly value system.
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